Cabaletta Bio Inc. highlighted progress for rese-cel (resecabtagene autoleucel; CABA-201), an autologous CD19 CAR T-cell therapy being studied across multiple autoimmune diseases. The company said a pivotal single-arm registrational study in myositis is enrolling and is designed to support a planned 2027 BLA submission, with a primary endpoint assessing moderate or major Total Improvement Score response at 16 weeks off immunomodulators and on no or low-dose steroids. The presentation also summarized safety observations across the first 40 treated patients in RESET studies, reporting that most events were no cytokine release syndrome or Grade 1 cytokine release syndrome and that most patients had no ICANS. Cabaletta noted development work on automated manufacturing with Cellares and described ongoing evaluation of dosing without preconditioning in select cohorts, with additional clinical updates expected in 2026 across SLE/lupus nephritis, systemic sclerosis, myasthenia gravis and pemphigus vulgaris. You can access the full presentation through the link below.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cabaletta Bio Inc. published the original content used to generate this news brief on March 02, 2026, and is solely responsible for the information contained therein.
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